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Date Posted
News Title
2023/05/24
Europe: EMA publishes 10-point guidance to address drug shortages
2023/05/23
US: FDA drafts regulatory considerations for complying with the Pediatric Research equity Act
2023/05/22
Europe: MDCG overhauls guidance on significant MDR changes
2023/05/19
AI: WHO warns against bias, misinformation in using AI in healthcare
2023/05/18
Australia: TGA applies class-wide boxed warning to JAK inhibitors
2023/05/17
US: FDA official offers overview of in-person, face-to-face ANDA meetings
2023/05/16
Europe: EMA’s annual report highlights regulatory activities in 2022
2023/05/15
US: FDA Releases two discussion papers to spur conversation about AI/ML in drug development and manufacturing
2023/05/13
GMP: Regulators discuss concerns, sustainable GMP compliance at ISPE Europe
2023/05/11
US: AI in drug manufacturing: Stakeholders call for harmonization, further guidance
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